Identity
- Trade Name
- AM Aligner EUDAMED
- Device Name
- AM ALIGNER NZ (NEW) EUDAMED
- Model / Reference
- AM ALIGNER EUDAMEDDE/CA09/00204204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851085006193 EUDAMED
- Basic UDI-DI
- 0851085006193TW EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
AM Aligner by Airway Management Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851085006193TW | Class I | Active |
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Manufacturer
- Manufacturer
- Airway Management Inc
- EUDAMED SRN
- US-MF-000039267
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 1feb10d0-86c5-4031-aadf-7f5ca6beb20b 61 fields · synced Jul 22, 2026